Pfizer's Epilepsy Drug Lyrica Succeeds in Pediatric Study

Pfizer Inc. PFE announced that a phase III study evaluating its epilepsy drugLyrica (pregabalin) in pediatric patients met the primary endpoint. The study was evaluating the use of Lyrica Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age, an indication for which Lyrica is not yet approved.

Top-line results from the study showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo which was the primary efficacy endpoint. However, treatment with Lyrica at lower dose of 7 mg did not result in statistically significant reduction in seizure frequency versus placebo.

These data along with the data from previous studies will be submitted to the FDA for Lyrica pediatric exclusivity determination.

Lyrica has already lost patent exclusivity in Europe, Russia, Turkey, Israel and Central Asia. In the United States, a favorable court decision in July 2012 regarding generic challenges should protect Lyrica from genericization through Dec 30, 2018.

Meanwhile, Pfizer is pursuing a six-month patent-term extension from the FDA for pediatric exclusivity, which, if granted, will keep generic competition at bay till June 2019. We believe that the positive data from the pediatric study may ease Pfizer’s effort to get pediatric exclusivity.

Other than epilepsy, Lyrica is indicated to treat post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury in the United States. Lyrica is also indicated to treat partial onset seizures in patients four years of age and older. Sales of Lyrica declined 1% to $1.13 billion in the first quarter of 2018.   

Shares of Pfizer have lost 1.5% year to date compared with industry’s decline of 3.8%.

Zacks Rank & Stocks to Consider

Pfizer has a Zacks Rank #3 (Hold)

Some better-ranked stocks from the same space worth considering are Illumina, Inc. ILMN, Ligand Pharmaceuticals LGND and Enanta Pharmaceuticals, Inc. ENTA. While Illumina sports a Zacks Rank #1 (Strong Buy), Ligand and  Enanta carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 23.17%. The stock has rallied 68.2% so far this year. The stock has rallied 22.9% so far this year.

Ligand’s earnings per share estimates have moved up from $4.07 to $4.37 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 39.6% year to date.

Enanta’s earnings per share estimates have moved up from 86 cents to $2.97 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 372.02%. The stock has rallied 80.8% so far this year.

Pfizer Inc. Price

Pfizer Inc. Price | Pfizer Inc. Quote

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